MAUDE Adverse Event Report: SYNTHES GMBH HOLLOW REAMER-COMPLETE FOR 2.7MM SCREWS

Catalog Number	309.25
Medical Device Problem Codes	Defective Device (2588); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.If additional information is made available, the investigation will be updated as applicable.Device history lot: part #: 309.25; lot #: 8708114; manufacturing site: (b)(4); release to warehouse date: 18 nov 2013.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 that on (b)(6) 2021, the patient underwent revision surgery to remove tcp implants.In the revision surgery, the 2.7mm locking screw broke during removal.When removing the broken locking screw remaining in the bone, the surgeon scraped around the locking screw with the 2.7mm hollow reamer and used the 2.7mm extraction bolt, but the bolt and the locking screw did not engage well.Eventually, the broken locking screw was removed.The surgery was completed within 30 minutes delay.The patient condition was stable.On (b)(6) 2020, the patient underwent open reduction internal fixation surgery treating distal radius with tcp implants.This complaint involves one (1) device.This report is for (1) hollow reamer-complete for 2.7mm screws.This report is 3 of 3 for (b)(4).

• Brand Name: HOLLOW REAMER-COMPLETE FOR 2.7MM SCREWS
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13002532
• Report Number: 8030965-2021-10197
• Device Sequence Number: 11940920
• Product Code: HTO
• UDI-Device Identifier: 07611819018334
• UDI-Public: (01)07611819018334
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 309.25
• Device Lot Number: 8708114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2013
• 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: EXTRACTION BOLT FOR 2.7MM SCREWS; UNK - SCREWS: 2.7 MM LOCKING
• Patient Sex: Unknown