MAUDE Adverse Event Report: STRYKER GMBH CONNECTING BOLT OMEGA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	704004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported that one of the connecting bolts on the dhs tray 704004, has snapped off inside a patient during a procedure.This could not be removed and has been left in the patient.**update** the case was completed with extended incision.There was a surgical delay of 15 minutes.The event happened whilst the lag screw was being inserted into the bone, the metal of the connecting bolt sheared off in the lag screw at point of contact with insertion handle.The patient was an elderly gentleman and the bone was not particularly hard, the surgeon was not inserting the lag screw at an extreme angle.Surgeon did not attempt to remove the bolt.**update** the surgeon further reported: ~15 cm was used.I extended proximally by ~5cm to gain a better view of the screw end and allow me to use the plate to turn the screw.4-6cm incision for a dhs would be appropriate for a 2 hole plate.Normal incision for a 4 hole plate is in the region of ~10 cm.Although it can be done via a minimally invasive this is not standard practice in (b)(6).Event occurred during insertion of the screw and with a normal degree of turning on the screw.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the threaded tip of the returned connecting bolt is indeed completely broken / snapped off.The surface of the breakage is homogenous which again indicates conformity to the given specification.Damages / deformations on the thread are clearly evident, which indicates that the connecting bolt may have not been place tighten enough and finally broke off during the applied mechanical force.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by possible inadequate assembly or simply too much mechanical force which was applied during lag screw insertion (possibly the connecting bolt may not have been placed tightened enough and subsequently the pins of the one step insertion wrench were not in position anymore).If any further information is provided, the investigation report will be updated.
Event or Problem Description
The customer reported that one of the connecting bolts on the dhs tray 704004, has snapped off inside a patient during a procedure.This could not be removed and has been left in the patient.**update** the case was completed with extended incision.There was a surgical delay of 15 minutes.The event happened whilst the lag screw was being inserted into the bone, the metal of the connecting bolt sheared off in the lag screw at point of contact with insertion handle.The patient was an elderly gentleman and the bone was not particularly hard, the surgeon was not inserting the lag screw at an extreme angle.Surgeon did not attempt to remove the bolt.**update** the surgeon further reported: 15 cm was used.I extended proximally by ~5cm to gain a better view of the screw end and allow me to use the plate to turn the screw.4-6cm incision for a dhs would be appropriate for a 2 hole plate.Normal incision for a 4 hole plate is in the region of ~10 cm.Although it can be done via a minimally invasive this is not standard practice in the uk.Event occurred during insertion of the screw and with a normal degree of turning on the screw.

• Brand Name: CONNECTING BOLT OMEGA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9258105
• Report Number: 0008031020-2019-01565
• Device Sequence Number: 3731383
• Product Code: LXH
• UDI-Device Identifier: 07613153054436
• UDI-Public: 07613153054436
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 704004
• Device Lot Number: 04898J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 01/07/2020
• 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
• Patient Age: 88 YR