MAUDE Adverse Event Report: SYNTHES GMBH CANNULATED STARDRIVE SCREWDRIVER/T40/277MM; SCREWDRIVERS

Catalog Number	03.010.520
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) it was reported that on (b)(6) 2021, the patient underwent open reduction internal fixation surgery for trochanteric fracture of femur.During the surgery, it was very hard to insert an end cap with the screwdriver.The surgery was completed within 30 minutes delay.No further information is available.Concomitant devices reported: unknown end cap (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1) cannulated stardrive screwdriver/t40/277mm.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/ investigation.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.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) it was reported that on (b)(6) 2021, the patient underwent open reduction internal fixation surgery for trochanteric fracture of femur.During the surgery, it was very hard to insert an end cap with the screwdriver.The surgery was completed within 30 minutes delay.No further information is available.Concomitant devices reported: unknown end cap (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1) cannulated stardrive screwdriver/t40/277mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: CANNULATED STARDRIVE SCREWDRIVER/T40/277MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12925333
• Report Number: 8030965-2021-09947
• Device Sequence Number: 4957836
• Product Code: HXX
• UDI-Device Identifier: 07611819499164
• UDI-Public: (01)07611819499164
• 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
• Report Date (Section B): 11/05/2021

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: 03.010.520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNK - END CAPS: FEMORAL NAIL
• Patient Sex: Unknown