MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - GUIDES/SLEEVES/AIMING: SLEEVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.025.040
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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) 2020, the orif was applied to a patient with the subtrochanteric fracture.During the surgery, when the surgeon tried to insert the protection sleeve into the device, only the tip of the protection sleeve could be inserted.The surgeon was unable to insert the device by turning it and then successfully inserted it using a hammer.There was difficulty detaching the protection sleeve from the device which were removed together off the nail.The surgery was successfully completed with a thirty (30) minute delay.No further information is available.Concomitant device reported: unknown nail (part# unknown, lot# unknown, quantity 1), unknown guides/sleeves (part# unknown, lot# unknown, quantity 1).This report is for one (1) 11.0mm/8.0mm protection sleeve 188mm for asls.This is report 1 of 2 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.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
Patient outcome was stable.
Event or Problem Description
This report is for an unknown protection sleeve.
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.D1, d2, d3, d4, g5 - 510k: this report is for an unknown protection sleeve/unknown lot.Part and lot number are unknown; udi number is unknown.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: UNK - GUIDES/SLEEVES/AIMING: SLEEVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9996127
• Report Number: 8030965-2020-03088
• Device Sequence Number: 19922351
• Product Code: LXH
• UDI-Device Identifier: 07611819865730
• UDI-Public: (01)07611819865730
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2020

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: 03.025.040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 04/27/2020; 05/15/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 05/07/2020; 05/26/2020
• 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: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - NAILS