MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.5MM CRUCFRM SCRWDRVR BLD W/SPRING HLDG SLV F/RESORB MQC; SCREWDRIVER

Catalog Number	314.431
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that this was a cranioplasty procedure performed on (b)(6) 2019.When the surgeon tried to fix a screw with the reported screwdriver (314.431), s/he was not able to raise the sleeve.The surgery was completed without surgical delay.Concomitant devices reported: unknown screw (part# unknown, lot# unknown, quantity 1) this report is for one (1) 1.5mm crucfrm screwdriver bld w/spring hldg slv f/resorb mqc.This is report 1 of 1 for (b)(4).
Additional 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.Investigation selection.Investigation site: cq zuchwil.Selected flow(s): damaged: visual | examples: deformed/bent/cracked/broken.Visual inspection: upon visual inspection of the complaint devices it can be seen that one of these two has deformed prongs of the collet chuck (on the tip) which should picked up and hold the screw, this thus confirming the complaint description.Otherwise the instrument in a good condition.The other part received is in a good condition, no further evaluation will be done as the other instrument is damaged.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 functional test is needed.Document/specification review: drawings and revisions are in accordance to dhr of production lot l688091.All relevant features are defined on the used drawing revisions of dhr of production lot l688091.The reported devices were assembled according to drawing, and those went through a 100% functional test (incl.Picked up and held the screw by the screwdriver), before they had left the production.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: unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error (handling issue or cleaning and sterilization error) may have taken place.To prevent such problems, it is necessary worn, incomplete or damaged instruments to replace.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part: 314.431.Lot: l688091.Manufacturing site: hägendorf.Release to warehouse date: february 27, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.
Additional 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: g4: awareness date reported on follow up 1 report as july 17, 2019 but should have been september 05, 2019.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: 1.5MM CRUCFRM SCRWDRVR BLD W/SPRING HLDG SLV F/RESORB MQC
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8892763
• Report Number: 8030965-2019-67216
• Device Sequence Number: 1400485
• Product Code: HXX
• UDI-Device Identifier: 07611819155404
• UDI-Public: (01)07611819155404
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 314.431
• Device Lot Number: L688091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 07/17/2019; 10/07/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/30/2019; 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCRDRIVERSHAFT-1.5 CRUCIF W/HOLD-SLEEVE; UNK - SCREWS: TRAUMA; SCRDRIVERSHAFT-1.5 CRUCIF W/HOLD-SLEEVE; UNK - SCREWS: TRAUMA