MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 4.9MM LOCKING BOLT 38MM; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 259.380

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Patient¿s weight is unknown.Date of event is unknown.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 a patient fell on the right side and had a femoral fracture.Patient was treated with blade, nail and two locking bolts on (b)(6) 2017.Post-operatively, it was detected that the proximal femoral nail antirotation (pfna) blade has been unlocked and it was dislocated.Patient revised on (b)(6) 2017.During revision surgery, it was also detected that both locking bolts were loose.Concomitant device reported: pfna 10 long r 130 l340 sst (part # 272.280s, lot # 9377650, quantity 1), pfna end cap extens.0 sst (part # 273.155s, lot # l455811, quantity 1).This report is for one (1) 4.9mm locking bolt 38mm.This is report 3 of 3 for complaint (b)(4).

Manufacturer Narrative

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.Part number: 259.380, synthes lot number: l282784.Release to warehouse date: 19.Jan.2017.Manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product development investigation was performed for the subject device.The present bolt was analysed for conformance to print specifications as well as the device history record was researched; no abnormal findings were identified.Manufacturing and inspection records indicated no problems with the lot in question.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances.The relevant dimensions were measured and they have fulfilled the specifications.The bolt shows that the implant is in a used condition without heavy damage.The surface of this implant has slightly wear marks it is not possible to determine where it is coming from.We can only assume, that this can be traced during removal or a possible instability of mention loosen bolt (according op-report; effect of local osteolysis).Measurement: feature/test/description: core diameter.Specification 4.3 +/- 0.05, actual 4.31.Gage 3-01-19788, results "pas." feature/test/description: outer diameter.Specification 4.95 max, actual 4.90.Gage 3-01-19788, results "pass." feature/test/description: length, specification 38 +/- 0.5, actual 38.11 gage 3-01-19788, results "pass." based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.

Manufacturer Narrative

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

It was reported that a dislocation of the femoral neck blade occurred in the patient and there was a suspicion of a chronic low-grade infection.The bolts prove to be entirely loosened with no further significant grip on the bone.It is to be assumed that this effect is the result of local osteolysis.

Manufacturer Narrative

Additional narrative: initially reported concomitant devices are no longer concomitant.Subject device has been received and is currently in the evaluation process.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

It was reported patient fell on the right side and suffered a dislocated intertrochanteric-subtrochanteric multiple fragment fracture of the femur, right side.Primary surgical treatment was not immediately possible due to patient¿s metformin intake.After easing the effects of the metformin, patient was implanted with a proximal femoral nail antirotation (pfna), a pfna blade, one (1) 38mm locking screw (bolt), one (1) 42 mm locking screw (bolt), and a pfna end cap on (b)(6) 2017.On unknown date, a dislocation of the femoral neck blade occurred in the patient, most notably through the re-opening of the sealed femoral neck blade.Accompanying this was a chronic persistent, opaque serous secretion over the entrance to the femoral neck blade.As a result, there was suspicion of a chronic low-grade infection.Patient was returned to surgery on (b)(6) 2017 where surgeon removed all hardware.During this procedure it was noted both screws (bolts) were loose with no significant grip on the bone.Surgeon assumed this to be the effect of local osteolysis.The wound was cleaned and the patient was closed.Unknown cultures were taken during this procedure.

• Brand Name: 4.9MM LOCKING BOLT 38MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7247740
• MDR Text Key: 99216362
• Report Number: 8030965-2018-50850
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819010369
• UDI-Public: (01)07611819010369(10)L282784
• Combination Product (y/n): N
• PMA/PMN Number: K970097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/08/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 259.380
• Device Lot Number: L282784
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/07/2018
• Supplement Dates Manufacturer Received: 02/08/2018; 02/08/2018; 03/07/2018
• Supplement Dates FDA Received: 03/05/2018; 03/06/2018; 03/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention