MAUDE Adverse Event Report: SYNTHES GMBH DRILL SLEEVE FOR 2.8MM DRILL BIT; GUIDE

Catalog Number	03.120.040
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j representative.The investigation could not be completed, no product was received; 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 on (b)(6) 2021, the surgeon set the plate for the guiding block at the demonstration.After the demonstration, by using the drill sleeve to remove the plate from the guiding block, but the plate couldn't be removed from the guiding block.Finally, remove the guiding block about 30 minutes.No further information is available.This complaint involves (3) devices.This report is for (1) drill sleeve for 2.8mm drill bit.This report is 2 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9 - device returned to manufacture.H6 - codes updated to imdrf codes.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device also please refer to (b)(4) local letter in pc level.Visual analysis of the returned sample revealed that lcp drill sleeve 3.5 f/drill bit ø2.8 03 the threads of the drill guide are slightly deformed, and no other issues were identified.The dimensional inspection was not performed for the lcp drill sleeve 3.5 f/drill bit ø2.8 03 due to alleged complaint condition.The functional test was not performed since all the parts were not received.The observed unable to assemble condition of the components is consistent with the complaint condition since the threads of the drill sleeve are deformed might be the reason for the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for lcp drill sleeve 3.5 f/drill bit ø2.8 03.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 - a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Evice 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: DRILL SLEEVE FOR 2.8MM DRILL BIT
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12367161
• Report Number: 8030965-2021-07199
• Device Sequence Number: 19937910
• Product Code: FZX
• UDI-Device Identifier: 07611819996304
• UDI-Public: (01)07611819996304
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.120.040
• Device Lot Number: 75P9167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDINGBLOCK F/LOCKING ATTACHMENT PLATE; UNK - PLTS: 4.5 MM NRW LTD. CNT LCKN CMPRSN PLTS; GUIDINGBLOCK F/LOCKING ATTACHMENT PLATE; UNK - PLTS: 4.5 MM NRW LTD. CNT LCKN CMPRSN PLTS