MAUDE Adverse Event Report: STRYKER GMBH JUNGBLUTH CLAMP FOR 3.5MM SCREWS, WIDE PRO; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number	705461
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Primary procedure, left acetabulum.It was reported that during the procedure, the clamp broke at the hinge.The broken part was easily seen and retrieved from the patient.A surgical delay of approximately three minutes was reported.
Additional Manufacturer Narrative
The reported event that jungbluth clamp for 3.5mm screws, wide pro was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by too much applied force during use (possibly misuse of the device).The device inspection revealed the following: the returned clamp is indeed not in working order anymore.A close up shows that the top part of the slider is indeed missing/broken off.Unfortunately the other broken piece has not been returned.Note that this clamp has to withhold high mechanical force when used.It was noted that for that kind of breakage, the clamps needed to be pulled apart from each other and not pushed together, which is actually the main function of the clamp, to push the fracture together in order to reduce it.Mechanical tests performed show that when used correctly, the screws counterpart will deform before any damage occur to the clamp, this gives us an indication that there might have been a misuse of the device.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
Primary procedure, left acetabulum.It was reported that during the procedure, the clamp broke at the hinge.The broken part was easily seen and retrieved from the patient.A surgical delay of approximately three minutes was reported.

• Brand Name: JUNGBLUTH CLAMP FOR 3.5MM SCREWS, WIDE PRO
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7732837
• Report Number: 0008031020-2018-00525
• Device Sequence Number: 1398218
• Product Code: HXD
• UDI-Device Identifier: 07613327131871
• UDI-Public: 07613327131871
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2018

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: 705461
• Device Lot Number: J35283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 09/17/2018
• 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: Other