MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH COMPLETE OPENING DRILL BIT/REAMER ASSEMBLY; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Catalog Number 03.168.004

Device Problems Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, the patient underwent an osteosynthesis to treat a femoral neck fracture.While the surgeon was reaming the bone, the reamer interfered with a non-synthes protection sleeve.This resulted in an unknown nut on the reamer to become loose and come off the driver shaft.The surgeon was unaware that the nut was loose and continued to apply force to the reamer without noticing that an unknown drill bit was advancing which caused the femoral head to break.Another surgeon noticed it, and immediately removed the reamer from the leg.The position of the nut on the drill bit was readjusted, and the operation was continued under the usual procedure.The procedure was successfully completed with a 30-minute surgical delay.The patient is in the hospital under observation.No patient consequence was observed.This report is for one (1) complete opening drill bit/reamer assembly.This is report 1 of 1 for (b)(4).

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.Additional information provided.Part: 03.168.004; lot: f-22748; manufacturing site: selzach; supplier: sphinx ag; release to warehouse date: november 27, 2017 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 dimensional, visual and functional 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: 2.Functional - loose visual inspection: the visual inspection has shown that the returned reamer is in almost brand-new condition, besides slight signs of usage at the nut.Functional test: problems of a malfunction of the reamer could not be detected.The reamer is adjustable in length, and the nut can be fixed and released as it should.No deviation could be detected.Dimensional inspection: as this investigation is focused on the functional issue and this was covered through the functional test performed, measurements of the features are not required for the complaint.Drawing/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.Summary: the reamer is rated as not confirmed, since the article has passed the functional test as described above.Based on the provided information, afterwards and without having the related/concomitant parts back, unfortunately we are not able to determine the exact cause of this complaint.The event description describes that the reamer interfered with a non-synthes protection sleeve.Based on this information, we cannot guarantee the same quality result in this constellation.We only can assume that an application error during use (because of the use of a non-synthes protection sleeve), could have led to this complained issue.In this relation, and for more details regarding ¿ream for insertion of plate and bolt,¿ we would like to draw your attention on page 15 & 16 in current technique guide.We conclude that the cause of failure is not due to any manufacturing non-conformances.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H6: code 3191 used to capture required surgical intervention.H11 corrected data: e3 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.

• Brand Name: COMPLETE OPENING DRILL BIT/REAMER ASSEMBLY
• 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: 8175902
• MDR Text Key: 130785634
• Report Number: 8030965-2018-59138
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819657304
• UDI-Public: (01)07611819657304
• 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
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.168.004
• Device Lot Number: F-22748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR