MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 16.5MM MEDULLARY REAMER HEAD

Catalog Number 352.165

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/07/2018

Event Type  Injury  

Manufacturer Narrative

Patient¿s height reported as 181 cms.Patient¿s weight is unknown.This report is for an unknown synream 16.5mm flexible reamer/unknown lot.Part and lot number are unknown; udi number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter phone number is not provided for reporting.The (510k): unknown, as specific part and lot numbers for reamer is not provided.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, the surgeon was using the synream 16.5mm flexible reamer without guide wire during right total hip joint replacement revision of a competitor product.During the procedure, the reamer tip became lodged and disengaged within the femoral canal and was unable to be retrieved.Surgeon did not use guide wire.Wire was open within the sterile field.No delay to procedure.No adverse effect.The patient was having a revision due to a periprosthetic fracture.Concomitant device reported: flexible shafts (part # unknown, lot # unknown, quantity unknown).This report is for one (1) unknown synream 16.5mm flexible reamer.This is report 1 of 1 for complaint (b)(4).

Event Description

Concomitant device reported: synream reaming rod ø2.5 short l950 (part # 352.032s, lot # l760308, quantity unknown).This report is for one (1) 16.5mm medullary reamer head.

Manufacturer Narrative

Additional narrative: products have been identified, catalog and udi, pma/510k: this information is now known.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.

• Brand Name: 16.5MM MEDULLARY REAMER HEAD
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7469976
• MDR Text Key: 106792665
• Report Number: 8030965-2018-53431
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.165
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR