MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH COMPRESSION SLEEVE FOR 3.0MM HEADLESS COMPRESSION SCREW; GUIDE

Catalog Number	03.226.000
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been requested.Without a lot number, the device history records review could not be completed as no product was received.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) 2020, the patient underwent a surgery with headless compression screws.During the surgery, the surgeon found that the instrument set delivered to the hospital contained the compression sleeve for 3.0 mm (03.226.000) instead of the compression sleeve for 2.4 mm (03.226.016).The surgeon had no choice but to insert 3.0 mm headless compression screws.He has concern for secondary fracture because the cortical bone became thinner due to the inserted screw size which is longer than planned one.There was no reported delay.The patient outcome was stable.This complaint involves two (2) devices.This is report 1 of 2 for (b)(4).

• Brand Name: COMPRESSION SLEEVE FOR 3.0MM HEADLESS COMPRESSION SCREW
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9907781
• Report Number: 8030965-2020-02465
• Device Sequence Number: 19005328
• Product Code: FZX
• UDI-Device Identifier: 07611819194267
• UDI-Public: (01)07611819194267
• 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
• Report Date (Section B): 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 03.226.000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention