MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS ADJUSTABLE DRILL GUIDE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number 48561011

Device Problems Mechanical Problem (1384); Component Missing (2306); Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 07/06/2017

Event Type  malfunction  

Event Description

It was reported that during surgery the surgeon drilled one hole, while drilling the second hole it was noticed there was no peg.The peg was nowhere to be found.It didn't physically appear to be in the patient, therefore fluro shots were taken to confirm.The surgery was successfully completed with a back up.At the end of the case an ap lateral was taken and it was still unable to confirm if the peg was in the patient.The whereabouts of the peg is unknown.The surgery was successfully completed with a back up, there was no adverse consequences to the patient reported.Unsure of how many times the instrument was used.Previously used successfully last month.

Manufacturer Narrative

No relevant manufacturing issues were identified as all units met specifications.A review of the manufacturing records confirmed the device is approximately 6 years old.The returned product was confirmed to have the in missing pin.A plausible root cause is normal wear of the device.

Event Description

It was reported that during surgery the surgeon drilled one hole, while drilling the second hole it was noticed there was no peg.The peg was nowhere to be found.It didn't physically appear to be in the patient, therefore fluro shots were taken to confirm.The surgery was successfully completed with a back up.At the end of the case an ap lateral was taken and it was still unable to confirm if the peg was in the patient.The whereabouts of the peg is unknown.The surgery was successfully completed with a back up, there was no adverse consequences to the patient reported.Unsure of how many times the instrument was used.Previously used successfully last month.

• Brand Name: OASYS ADJUSTABLE DRILL GUIDE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6755678
• MDR Text Key: 81577585
• Report Number: 0009617544-2017-00298
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613327271294
• UDI-Public: (01)07613327271294
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48561011
• Device Lot Number: 111097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1