MAUDE Adverse Event Report: SYNTHES GMBH 8.0MM/4.2MM DRILL SLEEVE 200MM; GUIDE

Catalog Number	03.010.065
Medical Device Problem Codes	Degraded (1153); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Roduct complaint # (b)(4).Reporter is a j&j representative.Investigation summary investigation flow- damage.Visual inspection: the complaint device drill sleeve (product code: 03.010.065, lot number:8349580) was returned to cq west chester for investigation.The opening on the drill sleeve for drill bit appeared deformed in shape and the green color marking was peeling.Device/defect was identified.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Dimensional inspection: complaint relevant or dimension of interest could not be measured due to the design of the device.Complaint confirmed: complaint can be confirmed based on the available information.Conclusion: the drill sleeve openings, the gap between two of the holders had became greater which could have been due to the repetitive use of the device.The complaint was confirmed based on the defect identified during visual inspection.A definitive root cause cannot be determined from the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: part # 03.010.065, lot number: 8349580, release to warehouse date: 04 apr 2013, manufactured by (b)(4), supplier: (b)(4).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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that devices are received as blind unit those are not associated with a complaint.This complaint was created to analyze.There was no procedure and patient involvement reported.This complaint involves six (6) devices.This report is for (1) 8.0mm/4.2mm drill sleeve 200mm.This is report 3 of 3 for complaint (b)(4).

• Brand Name: 8.0MM/4.2MM DRILL SLEEVE 200MM
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12878251
• Report Number: 8030965-2021-09780
• Device Sequence Number: 4472437
• Product Code: FZX
• UDI-Device Identifier: 07611819760929
• UDI-Public: (01)07611819760929
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

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 Catalogue Number: 03.010.065
• Device Lot Number: 8349580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/26/2021
• Date Device Manufactured: 04/04/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AIM-ARM F/EXPERT R/AFN RETROGR; CONNECSCR CANN W/INTERNAL M6X1 THREAD; DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/03.0; INSERT-HANDLE LONG F/EXPERT FN; TROCAR Ø4.2 F/03.010.065
• Patient Sex: Unknown