MAUDE Adverse Event Report: STRYKER TRAUMA KIEL K-WIRE GAMMA Ø3,2X450 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 12106450S

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

In in-coming inspection at distribution, it was found that there was a foreign material (kind of bug and fiber) in blister.This event was found on 1 of 100 units, lot#k0f0aa7 received on our (b)(4) and 1 of 35 units, lot#k0c628d received on our (b)(4).

Manufacturer Narrative

No deviations were found during review of the manufacturing and inspection documents (dhr).Both items returned were documented as faultless prior to distribution.The customer reported two events (insect and fiber within k-wire packages); both events could be confirmed; within the clear tube package of the k-wire with lot code k0f0aa7 an insect (approx.1mm long) was found, sticking on the label of the blister.A microscopically view revealed that the insect is most likely a juvenile bedbug (cimex lectularius).Within the clear tube package of the k-wire with lot code k0c628d a fiber was found, sticking on the label of the blister.A microscopically view revealed that the fiber is most likely a human hair.Both found residues (insect and hair) were classified as non-conformities, therefore, two new ncs were initiated, nc (b)(4) for the insect and (b)(4) for the hair.Review of the risk analysis did not identify any discrepancies.

Event Description

In in-coming inspection at distribution, it was found that there was a foreign material (kind of bug and fiber) in blister.This event was found on (b)(4) units, lot#k0f0aa7 received on our po# (b)(4) and (b)(4) units, lot#k0c628d received on our po# (b)(4).

• Brand Name: K-WIRE GAMMA Ø3,2X450 MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6919283
• MDR Text Key: 89469941
• Report Number: 0009610622-2017-00313
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 12106450S
• Device Lot Number: K0F0AA7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other