MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM CANNULATED DRILL BIT/QC 160MM; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Catalog Number 310.670

Device Problem Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided for reporting.Date of event is unknown.Additional device product code: gfa, gff, hsz.Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation but has not been received yet.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the surgeon had recurring problems with two (2) cannulated screw sets.The threaded guide wire with trocar and k-wire with double tip have been breaking off in-situ when used on patients.The drill bit was also noted to be dull.The surgeon stated that it has been happening in sixty percent of cases over the past twelve months.The surgeon did not believe that the staff have been putting used guide wires back in the set.Additionally, replacements were made with the drill bits only when they were dull because they were reusable.The surgeon also said that when using threaded guide wires, they were not breaking at the junction of the thread and the shaft, but rather in the shaft itself.There was no patient outcome reported.It was unknown if the procedure was successfully completed and if there was a surgical delay.This report is for one (1) 2.7mm cannulated drill bit/qc 160mm.This is report 3 of 3 for (b)(4).

Event Description

This report is for a 2.7mm cannulated drill bit/qc 160mm.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11 corrected data: b5.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Part: 310.670; lot: f-18520; manufacturing site: selzach; supplier: sphinx werkzeuge ag; release to warehouse date: december 23, 2015 the device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation selection investigation site: cq zuchwil; selected flow(s): 2.Device interaction/functional and 3.Damaged: visual | examples: deformed/bent/cracked visual inspection: upon visual inspection of the complaint device, it can be seen that on the proximal end of the device the tip is worn from use, this thus confirming the complaint description.Otherwise the article is in a good condition.Functional test: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no function test is needed.Document/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no document/specification review is needed.Dimensional inspection: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Summary: there is no particular information what's happened to this article by customer; unfortunately, we are not able to determine the exact reason for this occurrence, but we have to assume that wear and tear from often use over the years led to this damage or/and that during the operation an application error may have taken place.To prevent such problems, it is necessary for worn or damaged instruments to be replaced and/or to operated according to "ifu synthes cutting tools" or/and to operate according to "instrument wear due to normal wear." based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Based on the received request from surgeon (the surgeon wants to find out the tolerance difference between the outer diameter of the guide wires and the inner diameter of the cannulated drill bits) we have launched a "product development investigation" to evaluate customers query.Find following, the response from product development department: evaluation; per the complaint originates from australia which historically received product, therefore all designs listed above were accounted for in the theoretical clearance analysis.Throughout all historical designs and at maximum material condition: ¿ the guide wire features a maximum outer diameter of 1.25mm ¿ the drill bit features a minimal inner diameter of 1.25mm the resulting theoretical clearance is 0.00mm.Throughout all historical designs and at least material condition: ¿ the guide wire features a minimum outer diameter of 1.18mm ¿ the drill bit features a max inner diameter of 1.58mm the resulting theoretical clearance is 0.40mm conclusion; based on the evaluation performed above, the theoretical clearance between the guide wire 292.620 and the drill bit 310.670 varies per design between 0.00mm and 0.40mm.Number of parts d10 device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from australia reports an event as follows: it was reported that the surgeon had recurring problems with two (2) cannulated screw sets.The threaded guide wire with trocar and k-wire with double tip have been breaking off in-situ when used on patients.The three drill bits were also noted to be dull.The surgeon stated that it has been happening in sixty percent of cases over the past twelve months.The surgeon did not believe that the staff have been putting used guide wires back in the set.Additionally, replacements were made with the drill bits only when they were dull because they were reusable.The surgeon also said that when using threaded guide wires, they were not breaking at the junction of the thread and the shaft, but rather in the shaft itself.There was no patient outcome reported.It was unknown if the procedure was successfully completed and if there was a surgical delay.Concomitant devices: drill bit (part: 310.670, lot: f-24431, quantity: 1) k-wire with double tip (part: 292.520, lot: l831674, quantity: 4) k-wire with double tip (part: 292.520, lot: l554693, quantity: 1) k-wire with double tip (part: 292.520, lot: l475456, quantity: 4) k-wire with double tip (part: 292.520, lot: l786408, quantity: 1) guide wire with thread-tip with trocar (part: 292.620, lot: l728437, quantity: 6) guide wire with thread-tip with trocar (part: 292.620, lot: l901629, quantity: 3) guide wire with thread-tip with trocar (part: 292.620, lot: l656389, quantity: 1), this report is for a 1.25mm threaded guide wire 150mm.This is report 3 of 5 for (b)(4).

• Brand Name: 2.7MM CANNULATED DRILL BIT/QC 160MM
• Type of Device: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7890841
• MDR Text Key: 120830921
• Report Number: 8030965-2018-56461
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819018983
• UDI-Public: (01)07611819018983
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.670
• Device Lot Number: F-18520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 11/09/2018; 11/09/2018
• Supplement Dates FDA Received: 11/09/2018; 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE EVENT DESCRIPTION.