MAUDE Adverse Event Report: SYNTHES SELZACH REAMER Ø4.5/6.5 L450 F/HIP SCR F/EXPERT

Catalog Number 03.010.368

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) 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.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.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 (b)(4) reports an event in australia as follows: an open reduction internal fixation (orif) for a lower half femur fracture was performed.When drilling with the 4.5/6.5mm reamer up into the patient's femoral neck the drill tip broke off leaving about 30mm of the instrument tip retained in the patient, unable to be retrieved.The surgeon reported that the patient had extremely hard bone and experience difficulty drilling the initial 3.2mm wire into the patient's bone.The surgeon additionally reported that excessive axial pressure was likely necessary due to the hard bone.The surgeon was happy with the fixation achieved with the 1 x 6.5mm recon screw in the femoral neck and there was a good interference fit between nail and medullary canal.The patient outcome is unknown and there was reportedly no surgical delay.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation summary: the tip of the returned reamer is broken off as reported.The reamer broke between the second (ø4.5) and the third (ø6.5) step, which indicates that the first 25mm are broken off.Reviewing the device history records (dhr) showed no deviation to the specifications.The article was manufactured in march, 2015.The overall condition shows a broken tip and some marks from use; otherwise, the article is in very good condition.Though there is not enough evidence to determine exactly how often the instrument had been used prior to this surgery, it is likely that highly applied mechanical forces led to this breakage.In order to prevent such problems, it is necessary for worn or damaged instruments to be replaced.No product fault could be detected.Device history record review: manufacturing site: (b)(4) - manufacturing date: march 2, 2015.No non-conformance reports 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.Device 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: REAMER Ø4.5/6.5 L450 F/HIP SCR F/EXPERT
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5351402
• MDR Text Key: 35280987
• Report Number: 2520274-2016-10098
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2015

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: 03.010.368
• Device Lot Number: U221168
• Other Device ID Number: (01)07611819326958(10)U221168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention